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Behçet's Disease Overall Damage Index (BODI)

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ClinicalTrials.gov Identifier: NCT03803462
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Matteo Piga, University of Cagliari

Brief Summary:

Damage in vasculitis, as well as in other chronic inflammatory disorders, accrues over time resulting in impairment of quality of life, development of disability and increased mortality. For these reasons, damage represents an important outcome to be assessed and measured both in trials and clinical practice.

Currently, the most widely used assessment tool for damage in vasculitis is the Vasculitis Damage Index (VDI). However, VDI was developed for a no specific type of vasculitis and it appears to be more suitable for damage assessment in ANCA-associated vasculitis than in Behçet' disease (BD).

BD is a chronic and multisystem inflammatory disorder classified among vasculitides. As well as in other vasculitides, disease activity and treatment in BD can result in the development and accumulation of irreversible organ damage, such as blindness, tissue loss and a wide range of neurologic disorders. Recently the OMERACT has defined the Core Set domain of Outcome Measures for BD. Despite damage is included in the OMERACT outcome core set for rheumatic disease, a specific assessment tool for BD is currently not available.

The aim of this study is to develop and validate the first tool for describing and measuring organ damage in patients with Behçet Disease (Behçet's disease Overall Damage index - BODI).


Condition or disease Intervention/treatment
Behçet Disease Behcet's Disease Aggravated Other: Behçet's disease Overall Damage Index (BODI)

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Development and Preliminary Validation of the Behçet's Disease Overall Damage Index
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019



Intervention Details:
  • Other: Behçet's disease Overall Damage Index (BODI)
    BODI is a tool to document any organ damage that has occurred in patients since the onset of BD. It includes a form and an associated glossary with the definition of the items.


Primary Outcome Measures :
  1. Behçet's disease Overall Damage Index [ Time Frame: Baseline ]
    Prevalence and type of organ damage in Behçet's Disease assessed by experimental tool


Secondary Outcome Measures :
  1. Vasculitis Damage Index [ Time Frame: Baseline ]
    Prevalence and type of organ damage in Behçet's Disease assessed by non specific tool different

  2. Disease activity (Behçet disease actvity form) [ Time Frame: Baseline ]
    Prevalence and level of disease activity

  3. Health Related Quality of Life (HRQoL) [ Time Frame: Baseline ]
    Health Related Quality of Life measured by the eight scaled scores of the SF-36: 1) vitality; 2) physical functioning; 3) bodily pain; 4) general health perceptions; 5) physical role functioning; 6) emotional role functioning; 7) social role functioning; 8) mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A multicenter cohort consisting of 200-250 consecutive BD patients. Each participating investigator will enroll a cohort of 20-30 BD patients consecutively assessed in its own center.
Criteria

Inclusion Criteria:

  • BD diagnosis according to ICBD criteria;
  • disease duration ≥12 months;
  • age at enrolment ≥ 18 years;
  • Able to understand and voluntarily sign informed consent forms (ICFs) prior to the initiation of any study-specific assessments/procedures.

Exclusion Criteria:

  • unable to adhere to the protocol requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803462


Contacts
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Contact: Matteo Piga, MD +390706754069 matteopiga@unica.it
Contact: Alberto Floris, MD +3907051093348 albertofloris1@gmail.com

Locations
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Greece
Department of Rheumatology, Clinical Immunology and Allergy, University of Crete Recruiting
Heraklion, Greece
Contact: George Bertsias, Prof         
Contact: Nikos Cougas         
Italy
Rheumatology Unit, University of Bari Recruiting
Bari, Italy
Contact: Florenzo Iannone         
Contact: Giuseppe Lopalco         
Rheumatology Unit, Department of Clinical Sciences, AOU Sant'Anna University of Ferrara Recruiting
Ferrara, Italy
Contact: Govoni Marcello         
Contact: Andrea Lo Monaco         
Patient Association Delegates Active, not recruiting
Iglesias, Italy
Azienda Ospedaliero Universitaria Cagliari Recruiting
Monserrato, Italy, 09042
Contact: Alessandro Mathieu    07051093340    amah@unica.it   
Contact: Alberto Cauli         
Rheumatology Unit, Policlinico Le Scotte, University of Siena Recruiting
Siena, Italy
Contact: Luca Cantarini         
Portugal
Clinical Immunology Unit, Centro Hospitalar do Porto, Universidade do Porto Recruiting
Porto, Portugal
Contact: Joao Correia, Dr.         
Contact: Raquel Faria         
Neurology Department, Hospital Santo Antonio, Centro Hospitalar do Porto Recruiting
Porto, Portugal
Contact: Ana Martin Silva, Dr.         
Contact: Ernestina Santos         
Spain
Department of Autoimmune Diseases, Hospital Clinic, University of Barcelona Recruiting
Barcelona, Spain
Contact: Ricard Cervera, Prof.         
Contact: Gerard Espinosa, Dr.         
United Arab Emirates
Eye Institute at Cleveland Clinic Active, not recruiting
Abu Dhabi, United Arab Emirates
Sponsors and Collaborators
University of Cagliari
Investigators
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Principal Investigator: Matteo Piga, MD Azienda Ospedaliero Universitaria Cagliari

Publications:

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Responsible Party: Matteo Piga, Assistant Professor, University of Cagliari
ClinicalTrials.gov Identifier: NCT03803462     History of Changes
Other Study ID Numbers: BODI
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: .Within 6 months of study completion.
Access Criteria: Upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matteo Piga, University of Cagliari:
Damage
Outcome measure

Additional relevant MeSH terms:
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Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular